ETANERCEPT-YKRO | B761066 | SAMSUNG BIOEPIS CO LTD
Earliest legal licensure (12-year BPCIA floor)
The 12-year reference-product exclusivity is the non-carveable floor — the earliest FDA could license a biosimilar for any indication. Unverified estimate — derived from the earliest available approval record (Apr. 25, 2019), not an FDA-stated exclusivity date. Shown with lower confidence than a Purple Book value.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Apr. 25, 2031 | 4y 9mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Apr. 25, 2031 | 4y 9mo remaining | 12-year RPE floor |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
First-interchangeable exclusivity (§ 262(k)(6)): Dec. 25, 2025 — blocks other interchangeable designations only. It never gates plain biosimilar licensure and does not enter any entry-LOE above.
Marketing-entry ceiling (litigation risk)
Patents do not gate FDA licensure of a biosimilar — FDA licenses biosimilars (full or carved label) without adjudicating any patent. These are a practical marketing-entry ceiling resolved in the § 262(l) patent dance and ordinary litigation. A formulation/compound patent caps practical skinny entry via litigation (Regeneron v. Mylan); a method-of-use patent is carveable and gates nothing.
Latest formulation/compound patent 12318447(formulation)· AI-discovered, not Purple-Book-listed · relevance 60/100. This caps practical skinny-label entry; it does not move the licensure floor above.
26 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 22 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12325737 | Other | Jun. 5, 2045Active | Discovered |
| 12318447 | Formulation/compound | May. 29, 2045Active | Discovered |
| 12312381 | Other | May. 22, 2045Active | Discovered |
| 12290666 | Other | May. 1, 2045Active | Discovered |
| 12269843 | Other | Apr. 3, 2045Active | Discovered |
| 11952399 | Other | Apr. 4, 2044Active | Discovered |
| 11939367 | Formulation/compound | Mar. 21, 2044Active | Discovered |
| 11813328 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11486883 | Other | Oct. 27, 2042Active | Discovered |
| 11427627 | Formulation/compound | Aug. 25, 2042Active | Discovered |
| 11312745 | Other | Apr. 21, 2042Active | Discovered |
| 11254963 | Other | Feb. 17, 2042Active | Discovered |
| 11198732 | Formulation/compound | Dec. 9, 2041Active | Discovered |
| 11040102 | Formulation/compound | Jun. 17, 2041Active | Discovered |
| 10676772 | Other | Jun. 4, 2040Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Approved Biosimilars
Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.
Top 50 of 90 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2019-04-30 | Terminated 2021-11-03 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.